phase ii trial to evaluate the efficacy and safety of hm61713 as the 1st-line nsclc anticancer therapy

Conditions: Non Small Cell Lung Cancer

Summary: a multi-center, single-arm. phase 2 exploratory trial to evaluate the efficacy and safety of hm61713 as the 1st-line anticancer agent in none-small cell lung cancer patients with egfr mutation

hm-emsi-201 study targets nsclc patients with egfr mutations by hm61713 anticancer drug as the first-line therapy.

Eligibility criteria:
inclusion criteria: * aged at least 19 years at the time of signing informed consent * cytologically or histologically confirmed, advanced or metastatic nsclc which is not amenable to curative surgery (stage iiib or iv) * documented egfr mutations (excluding exon 20 insertion) * at least one lesion that can be used as a measurable lesion per recist version 1.1 * performance status under 1 per ecog score * life expectancy of at least 12 weeks * adequate hematological and biological functions * provide voluntary consent to participate the study and sign the written consent form exclusion criteria: * treatment of chemotherapy, biological therapy or immunotherapy for anticancer therapies of stage iiib or iv nsclc (excluding adjuvant/neoadjuvant chemotherapy, radiotherapy or radiochemotherapy prior to more than 6 months from the first dose of study treatment * history of treatment with an egfr targeting small molecule or antibodies * any non-study related significant surgical procedures requires general anesthesia or breathing apparatus within the past 4 weeks of the first dose of study treatment (excluding video-assisted thoracoscopic surgery or open-and-closed surgery prior to the past 2 weeks of the first dose of study treatment) * history of any other malignancy within 5 years of study participation (other than curatively treated cervical cancer in situ, non-melanoma skin cancer, superficial bladder tumors unless it has been definitively treated with no evidence of relapse or recurrence within the past 3 years) * clinically significant uncontrolled conditions of infectious disease including active infection that requires parenteral antibiotics (except when conditions are definitively treated or controlled) * spinal cord compression, leptomeningeal carcinomatosis, symptomatic or uncontrolled brain metastasis * presence or history of ild or pulmonary fibrosis * nyha class iii or iv cardiac insufficiency, uncontrolled hypertension, experienced unstable angina pectoris or cardiac infarction within 6 months, uncontrolled cardiac arrhythmia or clinically significant abnormal cardiovascular activities * lvef \< 40% * presence or history of pancreatitis or serum amylase \> 1.5xuln * inability to swallow the formulated product or gastrointestinal tract abnormalities which would preclude administration or absorption of study medication * mental or congenital disabilities (e.g. dementia or epilepsy) which would preclude understanding of informed consent or following the study protocol * history of hypersensitivities to investigational drug or related similar class drugs * pregnant or breast feeding * unwillingness of adequate contraception during study treatment and at least 2 months after treatment * unwillingness of following procedures of study protocol or follow-up assessments; unable to follow up for long term for psychological, social, family problem or geographical reasons * history of treatment with other investigational drugs or investigational medical devices prior to 28 days of the first dose of study treatment * in the opinion of the investigator, the patient is an unsuitable candidate to the study * ecg finding of qtcf \> 450 msec at rest

Keywords: hm61713 epidermal growth factor receptor mutation positive nsclc olmutinib